Auditing, Clinical Nursing, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Community Health, Dental Insurance, Electronic Data Capture (EDC), FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), Health Insurance, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Internal Audit, Maintain Compliance, Marketing, Microsoft Office, Operations Management, Organizational Skills, Process Improvement, Quality Assurance, Quality Management, Regulations, Regulatory Submissions, Research Nursing, Standard Operating Procedures (SOP), Startup
Clinical Research Regulatory Coordinator
AIH Research — Advancing Health Through Innovation
Join a mission-driven research team transforming access to clinical trials for diverse and underserved communities. AIH Research partners with Community Health Network to bring FDA‑approved studies to patients who need them most—improving health equity while delivering high‑quality data to sponsors.
We’re seeking a Clinical Research Regulatory Coordinator who’s sharp, organized, and passionate about compliance, quality, and moving research forward.
REQUIRES ON-SITE WORK
What You’ll Do
- Lead and manage regulatory operations across multiple clinical trials
- Ensure full compliance with ICH GCP, FDA regulations, and ethical standards
- Maintain IRB/CLIA/IBC submissions, regulatory binders, CVs, training logs & site certifications
- Oversee quality assurance, conduct internal audits, support sponsor inspections
- Manage regulatory language for marketing materials
- Maintain and update SOPs; support continuous process improvement
- Oversee feasibility submissions and track study startup milestones
- Support the Associate Director with additional regulatory projects
What You Bring
- Deep knowledge of GCP, human subject protections, and FDA trial regulations
- Experience with eReg, CTMS, EDC systems, and strong Microsoft Office skills
- Ability to manage complex regulatory workflows with precision and independence
- Associate degree in clinical research, nursing, or related field
- 3–5 years clinical research experience + 2–3 years regulatory experience
- Bachelor’s degree preferred
- Clinical research certification preferred (CCRP, CCRC, ACRP-CP)
- Feasibility and SOP experience preferred
Why You’ll Love Working With Us:
- 100% Paid Employee Health & Dental Insurance.
- Paid Time Off + Birthday Leave + Sick Time.
- $200 Annual CE Stipend.
- Career Growth & Flexible Schedules.
- Make a Real Impact in Underserved Communities.
Will add later...
Benefits
Flexible schedule, Paid time off, Health insurance, Dental insurance, Vision insurance, Life insurance, Disability insurance, Referral program, Employee discount, Pet rider program, Mileage reimbursement, OtherJob Type
Full timeSchedule
8 hour shift, Monday to Friday